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Completed

NCT Number: NCT01250925

Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface

The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

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Key information

Conditions

Myopia Eye Diseases Refractive Error Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

An estimated 40 million people in the United States wear contact lenses, with approximately 38 million soft lens wearers and 2 million rigid gas permeable lens wearers. The ocular surface has been shown to respond to the introduction of foreign materials with upregulation of proinflammatory mediators, leading to an increase in inflammation. The corneal can show a foreign body immune response to contact lenses. The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across the three lens care regimens in new contact lens wearers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be 18 years of age and may be of any race and either gender.
  • Subjects must not have ever worn contact lenses.
  • Subjects must have normal, healthy eyes.

Exclusion criteria

  • Subjects must not use additional lens cleaners.
  • subjects must not have any ocular or systemic disease.
  • Subjects must not have history of ocular surgery/trauma within the last 6 months.

Treatment and study plan

ReNu MultiPlus® MultiPurpose Solution

Drug

Contact lens care regimen

OPTI-FREE® RepleniSH®

Drug

Contact Lens care regimen

Clear Care®

Drug

Contact lens care regimen

Primary outcomes

  1. Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  2. Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  3. Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  4. Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  5. Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  6. Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  7. Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  8. Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  9. Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

  10. Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)

    Time frame: Six weeks

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

Secondary outcomes

  1. Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events

    Time frame: Six weeks

    The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Collaborators

  • Alcon Research
  • University of Iowa

Registry information

Official study title

Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface: A Laser In Vivo Confocal Microscopy Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2010
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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